Drug Target Review

DECEMBER 4, 2024

VHH-based therapies have been clinically-validated many times with multiple products in numerous indications, including for long-term dosing. Confo has an extensive knowledge in the optimization of VHH-based products for human use.

Small Molecule

Drug Target Review

JUNE 19, 2025

It produces a harmful by-product, NAPQI, which can cause serious hepatic and renal damage. South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. Liver-safe by design One of the long-standing issues with paracetamol is its liver toxicity.

Clinical Trials

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. His graduate research focused on the structural characterisation and synthesis of marine natural products.

Drugs

The Pharma Data

JUNE 11, 2025

Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. This move is in line with BeOne’s global commercialization strategy, which emphasizes product accessibility and regional adaptability. Source link

FDA Approval

The Pharma Data

JUNE 25, 2025

The company announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory body of the European Medicines Agency (EMA), has issued a positive opinion recommending approval of a new tablet formulation of BRUKINSA for all currently approved indications. Alignment with U.S.

Packaging

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Jump up to: a b “Orserdu Product information” Union Register of medicinal products. 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 18 September 2023.

FDA

Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The Altascientist, Issue 7, pg. The Altascientist, Issue 7, pg.

Therapies

New Drug Approvals

JULY 25, 2025

Finally, the acetate group is cleaved under basic conditions to give crude Vamorolone, which was recrystallized from iPrOH to obtain the pure product. The product was filtered off, washed with H 2 O (3 x 0.5 The product was filtered off, washed with H 2 O/MeCN 4:1 (2 x 0.5 and DMAP (16.1 g, 0.132 mmol, 0.10 HCI (950 mL, 0.95

FDA

DrugBank

JUNE 18, 2025

Regulatory agencies require pharmaceutical companies to submit preclinical and clinical trial data covering toxicology, pharmacokinetics, pharmacodynamics, and long-term safety monitoring. This underscores the role of regulatory oversight in ensuring manufacturing consistency and product safety.

Drug Development

New Drug Approvals

JULY 19, 2025

3] In 2021, it was approved by the National Medical Products Administration of China for the treatment of complicated skin and soft tissue infections (cSSTI). [3] 3] In 2021, it was approved by the National Medical Products Administration of China for the treatment of complicated skin and soft tissue infections (cSSTI). [3]

Clinical Trials

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials

New Drug Approvals

JUNE 11, 2025

Substitution of 2-(piperazin-1-yl)pyrimidine ( GEPI-001 ) with 1,4-dibromobutane ( GEPI-002 ), followed by ring opening and addition, generated the final product Gepirone. An efficient approach of Gepirone has been disclosed in Scheme 11 [41]. A further approach for the synthesis of gepirone is described in the literature (Ί).

FDA

New Drug Approvals

JULY 12, 2025

The safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 are currently being evaluated in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. Therefore, the broad inhibition of FGFR isoforms may be effective against different types of tumors. The filtrate was concentrated under reduced pressure.

Production

The Pharma Data

JUNE 9, 2025

Since its launch in 2023, the product has quickly gained recognition for its high and sustained efficacy throughout the RSV season and is supported by a comprehensive body of real-world evidence involving hundreds of thousands of infants.

Virus

New Drug Approvals

JUNE 25, 2025

The disease is characterized by metabolic defects in the production and utilization of carbohydrates which result in the failure to maintain appropriate blood glucose levels. metformin) are thought to act primarily by decreasing hepatic glucose production. clinical candidate currently in Phase 2 development. B) Biguanides (e.g.,

Small Molecule

Alta Sciences

APRIL 24, 2025

And in this case study, we demonstrate how we used a proactive strategy to establish a clear differentiation between anticipated pharmacological responses and potential safety-related findings and to provide the client with high-quality toxicology and pharmacokinetic data crucial for their IND submission.

Small Molecule

The Pharma Data

JULY 3, 2025

This strategic enhancement of its existing site marks a significant milestone in the company’s mission to support the development and production of advanced therapeutic and diagnostic products. source link

Science

New Drug Approvals

APRIL 19, 2025

This is then added with 10 100 equivalents of starting product (S)-(2,2-dimethyl-1,3-dioxolan-4-yl)methyl 3-(4-hydroxyphenyl)propanoate 3, preferably 20 50 equivalents, then with a polar aprotic solvent, preferably methyl tert -butyl ether (MTBE). The resulting Landiolol hydrochloride 2 has very high enantiomeric purity. 20 November 2023.

FDA

New Drug Approvals

APRIL 18, 2025

PMC 10583973. PMID 37216921. External links “Crinecerfont (Code C174708)” NCI Thesaurus. gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Prete A, Auchus RJ, Ross RJ: Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia. Eur J Endocrinol. 2021 Nov 30;186(1):R1-R14. doi: 10.1530/EJE-21-0794.

FDA

PPD

APRIL 14, 2025

Were also uniquely able to deliver a full suite of end-to-end offerings that include: Thermo Fisher Scientific manufacturing for production continuity from clinical trials to commercial scale.

Clinical Trials

Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.

Drug Development

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively). In 2023, the FDA approved a 2.7

FDA Approval

New Drug Approvals

JULY 28, 2025

The main production method of the key chiral intermediate is shown as follows: reducing nitro in 3-nitro-1H-pyrazole substrate into amino, protecting free amino, carrying out N-alkylation reaction with (R) – (-) -2, 3-O-isopropylidene glycerol-OH derivative active intermediate, and deprotecting to obtain the final product.

Small Molecule

New Drug Approvals

JULY 21, 2025

Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production. 0115]Step 2: Synthesis of intermediate (III-1) [0116]The product from the previous step (1.4 This may prevent or treat chemotherapy-induced thrombocytopenia. kg, yield 81%). kg, yield 94%).

Small Molecule

New Drug Approvals

JULY 18, 2025

The method requires a total of 15 steps of reaction to obtain the target product. Low cost, high cost, not suitable for industrial production. The crude product was purified by silica gel column chromatography (ethyl acetate: petroleum ether =1:10) to obtain a white solid (yield: 41.2%). Example 1 Accurately weigh 4.86

RNA

ASPET

AUGUST 4, 2023

The natural product goldenseal is a clinical inhibitor of CYP3A activity, as evidenced by a 40-60% increase in midazolam AUC after coadministration with goldenseal. The objective of this study was to mechanistically assess the pharmacokinetic goldenseal-midazolam interaction using an integrated in vitro - in vivo - in silico approach.

Pharmacokinetics

ASPET

MAY 22, 2024

In this review, we will examine what is currently known about CBC with regards to pharmacodynamics, pharmacokinetics, and receptor profile. Following easier access to hemp, CBC products are commercially available over-the-counter and are being widely utilized with little or no evidence of their safety or efficacy.

Pharmacokinetics

LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. In order to start building a case for or against a target, I like to start with genetics – first human and then mouse.

Production

Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Focus Area: Increasing Access to Complex Generic Drug Products. For instance, the U.S. Retrieved from [link] U.S.

Drug Development

Chemical Biology and Drug Design

JANUARY 29, 2024

In first method, catalytic amidation was carried out under microwave irradiation using Ceric Ammonium Nitrate (CAN) as a green catalyst where as in second conventional method; CDI was used as a significant coupling reagent to optimize reaction condition and yield of product. The results showed slight toxic nature of new compounds.

Pharmacokinetics

ASPET

SEPTEMBER 16, 2024

We further demonstrate that daily oral treatment with a novel mitofusin activator derived from the natural product piperine can reverse these neurological phenotypes. Here, we describe motor and sensory neuron dysfunction characteristic of clinical CMT type 2A in a CRISPR/Casp-engineered Mfn2 Thr105Met (T105M) mutant knock-in mouse.

Small Molecule

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA

Chemical Biology and Drug Design

MARCH 6, 2024

Abstract Targeting pro-inflammatory cytokines and their production is found to be of therapeutic benefit for the regulation of inflammation in various chronic autoimmune diseases. cell lines along with the testing of nitrite production effect (Griess assay) and cytotoxicity (MTT) analysis.

Pharmacokinetics

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. LYT-100 is PureTech’s most advanced wholly-owned product candidate. About LYT-100.

Pharmacokinetics

Alta Sciences

AUGUST 7, 2023

[NEW EBOOK] Safety Assessment for Ophthalmic Products tchichekian Mon, 08/07/2023 - 19:08 HTML Excellence in Ophthalmic Safety Testing Altasciences has been conducting ophthalmic safety testing for decades, with all global regulatory submissions from our studies approved for design, conduct, and data integrity.

Production

DrugBank

SEPTEMBER 19, 2024

However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges.    Pharmacokinetics of Oral Drugs  Orally administered drugs undergo a series of biochemical processes that can affect their bioavailability and their clinical efficacy.

Drugs

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

Packaging